RecruitingPhase 1Phase 2NCT04481763

A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast


Sponsor

Jiangxi Provincial Cancer Hospital

Enrollment

20 participants

Start Date

Jul 14, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a open-labeled, single-arm, Investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with radiotherapy in patients with early triple-negative breast cancer. We will enroll 60 subjects. This study aims to evaluate the efficacy and safety of camrelizumab combined with radiotherapy in the treatment of early TNBC。


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug called camrelizumab to radiation therapy improves outcomes for women with early-stage triple-negative breast cancer (a type that does not respond to hormone therapies or HER2-targeted drugs) after mastectomy. **You may be eligible if...** - You are a woman aged 18–74 with confirmed triple-negative breast cancer - Your tumor is large or has spread to lymph nodes (specific staging criteria apply) - You are planning breast-conserving radiation therapy after mastectomy - Your organ function (blood counts, liver, kidneys) meets acceptable levels **You may NOT be eligible if...** - You have received prior treatment for this breast cancer - You have significant organ dysfunction - You are pregnant or breastfeeding - You have an active autoimmune condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab

Camrelizumab is 200 mg iv. administered every 2 weeks for 3 cycles with radiotherapy ( 50gy, 25 times for 5weeks)

RADIATIONradiotherapy

radiotherapy


Locations(1)

Chunling Jiang

Nanchang, Jiangxi, China

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NCT04481763


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